Biotech Values

[DewDiligence]

MNTA 2015-2016 News Flow

[Updated for Glatopa launch and other matters.]


Copaxone program

• Early August: MNTA’s 2Q15 financial results will reveal Glatopa sales and MNTA’s take. (My estimate for 2Q15 top-line sales is $70M—see #msg-115576637 and #msg-115577517.)

• Aug/Sep 2015: USPTO inter partes review of Teva’s patent for 40mg (thrice-weekly) formulation of Copaxone.


Lovenox program

• Any day : Ruling from Appellate Court on Safe Harbor issue. The U.S. Solicitor General recently sided with NVS/MNTA by asserting that Amphastar’s (and Teva’s) invoking the Safe Harbor in their defense was inappropriate (https://www.dropbox.com/s/zxz9pfu2kfh3t7w/document.pdf ); if the CAFC sides with the SG, the Lovenox patent case will finally be tried on the merits and NVS/MNTA may be able to claim damages for patent infringement—see #msg-115468100.


FoB program

• 2H15: Partnership deal for FoB compounds other than Humira (which is partnered with BXLT, the Baxter spin-off).

• Late 2015: Results of phase-1 trial and start of phase-3 trial for Humira FoB.. Regulatory submissions expected in 2017 if no hitch.

• 2016: Orencia FoB starts phase-1.

• Timing unknown: New pipeline disclosures re M597, M615, M282, M706, M730, or M740. (See slide #53 at link in #msg-107107809.)


Necuparanib program

• 2016: Results of phase-2 trial in pancreatic cancer. Primary endpoint is overall survival. (The trial is listed at http://www.clinicaltrials.gov/ct2/show/NCT01621243 .)


Miscellaneous

• Timing unknown: New disclosures re recombinant IVIG program and other early-stage development programs.